Clearmind DSMB clears CMND-100 to advance into AUD patients
Clearmind Medicine has received unanimous approval from its independent Data and Safety Monitoring Board (DSMB) to advance its Phase I/II trial of CMND-100 into patients with moderate to severe Alcohol Use Disorder (AUD). The decision follows successful completion of Part A of the study, in which the oral candidate met its primary safety endpoint across all planned dose levels in healthy volunteers.
CMND-100 is an oral formulation of 5-methoxy-2-aminoindane (MEAI), which Clearmind is developing as a non-hallucinogenic neuroplastogen. The compound is intended to promote adaptive neuroplasticity without the perceptual effects associated with classical psychedelics, a profile the company says could support scalable treatment models that do not require intensive clinical supervision.
Into the patient population
Part B of the trial, which the DSMB has now cleared, will enrol two sequential cohorts of six patients each, receiving 80 mg and 160 mg doses of CMND-100 respectively. This marks the first time the compound will be tested in individuals with AUD rather than healthy volunteers. The cohorts will be assessed for safety, tolerability, and early signals of clinical activity, including any reduction in alcohol consumption and craving. Concurrently, Part C will evaluate a fixed 160 mg daily dose over five consecutive days in healthy participants under a double-blind, placebo-controlled design to further characterise the drug's safety profile.
Dr Adi Zuloff-Shani, chief executive of Clearmind, said the advancement represented "a meaningful step toward advancing a potential new treatment option for individuals living with AUD," adding that the company is now positioned to evaluate CMND-100 "in the population it is designated to help." The trial is being conducted at Johns Hopkins University, Yale School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center.
Market and competitive context
AUD is a substantial and underserved therapeutic area. Approved pharmacological options remain limited, with naltrexone, acamprosate and disulfiram representing the mainstay of treatment, all with modest adherence rates and limited real-world uptake. Interest in psychedelic-derived and neuroplastogen approaches has grown considerably, with psilocybin and ketamine attracting significant research attention for addiction and mood disorders. Clearmind's non-hallucinogenic positioning differentiates CMND-100 from classic psychedelic programmes, at least in theory, by removing the requirement for supervised dosing sessions, which represent a key practical and regulatory barrier to broader adoption.
Several other companies and academic groups are exploring MEAI and related compounds, though the clinical dataset in AUD patients remains thin across the field. Clearmind's Phase I/II, running at high-profile academic sites including Johns Hopkins and Yale, adds credibility to the programme. Investors will nonetheless be focused on whether Part B generates meaningful preliminary efficacy signals, given that safety data from healthy volunteers, while necessary, is not sufficient to inform commercial positioning. The company has not provided a timeline for Part B completion or an expected date for topline data.
Clearmind is listed on Nasdaq under the ticker CMND and holds a patent portfolio of 19 families, including 32 granted patents covering its neuroplastogen compounds.